Translational Medicine Research Center, Sirius University of Science and Technology, Sochi, Russia.
Zheln, Toronto, ON, Canada.
Front Immunol. 2024 Oct 3;15:1457327. doi: 10.3389/fimmu.2024.1457327. eCollection 2024.
To comprehensively identify and provide an overview of or clinical studies of nucleic acids (NA)-based vaccines against TB we included human or animal studies of NA vaccines for the prevention or treatment of TB and excluded or research, studies of microorganisms other than , reviews, letters, and low-yield reports.
We searched PubMed, Scopus, Embase, selected Web of Science and ProQuest databases, Google Scholar, eLIBRARY.RU, PROSPERO, OSF Registries, Cochrane CENTRAL, EU Clinical Trials Register, clinicaltrials.gov, and others through WHO International Clinical Trials Registry Platform Search Portal, AVMA and CABI databases, bioRxiv, medRxiv, and others through OSF Preprint Archive Search. We searched the same sources and Google for vaccine names (GX-70) and scanned reviews for references. Data on antigenic composition, delivery systems, adjuvants, and vaccine efficacy were charted and summarized descriptively.
A total of 18,157 records were identified, of which 968 were assessed for eligibility. No clinical studies were identified. 365 reports of 345 animal studies were included in the review. 342 (99.1%) studies involved DNA vaccines, and the remaining three focused on mRNA vaccines. 285 (82.6%) studies used single-antigen vaccines, while 48 (13.9%) used multiple antigens or combinations with adjuvants. Only 12 (3.5%) studies involved multiepitope vaccines. The most frequently used antigens were immunodominant secretory antigens (Ag85A, Ag85B, ESAT6), heat shock proteins, and cell wall proteins. Most studies delivered naked plasmid DNA intramuscularly without additional adjuvants. Only 4 of 17 studies comparing NA vaccines to BCG after challenge demonstrated superior protection in terms of bacterial load reduction. Some vaccine variants showed better efficacy compared to BCG.
https://osf.io/, identifier F7P9G.
为了全面识别和概述针对结核病的核酸（NA）疫苗的临床研究，我们纳入了预防或治疗结核病的 NA 疫苗的人体或动物研究，排除了疫苗开发、非的微生物研究、综述、信件和低产报告。
我们检索了 PubMed、Scopus、Embase、选定的 Web of Science 和 ProQuest 数据库、Google Scholar、eLIBRARY.RU、PROSPERO、OSF 注册中心、Cochrane 中心、EU 临床试验注册中心、clinicaltrials.gov 以及通过世界卫生组织国际临床试验注册平台搜索门户、AVMA 和 CABI 数据库、bioRxiv、medRxiv 等其他来源的数据库。我们还通过 OSF 预印本存档搜索搜索了疫苗名称（GX-70）和评论中的参考文献。我们对抗原组成、传递系统、佐剂和疫苗功效的数据进行了图表绘制和描述性总结。
共确定了 18157 条记录，其中有 968 条被评估为符合条件。未发现临床研究。综述中纳入了 345 项动物研究的 365 份报告。342 项（99.1%）研究涉及 DNA 疫苗，其余三项则关注 mRNA 疫苗。285 项（82.6%）研究使用了单抗原疫苗，而 48 项（13.9%）则使用了多抗原或与佐剂的组合。只有 12 项（3.5%）研究涉及多表位疫苗。最常使用的抗原是免疫优势分泌抗原（Ag85A、Ag85B、ESAT6）、热休克蛋白和细胞壁蛋白。大多数研究将裸露质粒 DNA 肌肉内给药，不添加额外的佐剂。在 17 项比较 NA 疫苗与卡介苗在挑战后的保护效果的研究中，仅有 4 项研究表明，在减少细菌负荷方面，NA 疫苗具有优势。一些疫苗变体与卡介苗相比显示出更好的疗效。
https://osf.io/，标识符 F7P9G。
